Details for New Drug Application (NDA): 211194

NDA 211194 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, which is a drug marketed by Abbott, Fresenius Kabi Usa, Icu Medical Inc, Miles, and B Braun, and is included in six NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER is dextrose; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

Summary for 211194

Tradename:	DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	dextrose; sodium chloride
Patents:	0

Pharmacology for NDA: 211194

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 211194

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	211194	ANDA	Fresenius Kabi USA, LLC	63323-867	63323-867-10	10 BAG in 1 CASE (63323-867-10) / 1000 mL in 1 BAG
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	211194	ANDA	Fresenius Kabi USA, LLC	63323-867	63323-867-74	20 BAG in 1 CASE (63323-867-74) / 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5GM/100ML;300MG/100ML
Approval Date:	Aug 26, 2020	TE:	AP	RLD:	No

Complete Access Available with Subscription